Which role is responsible for submission of raw data, documentation, protocols, specimens, and final reports or archives at the end of a GLP study?

Which role is responsible for submission of raw data, documentation, protocols, specimens, and final reports or archives at the end of a GLP study?

• A. Sponsor
• B. Study Director
• C. Quality Assurance Unit
• D. FDA

Answer: (B)

In GLP, the person coordinating the study’s conduct and data integrity is responsible for ensuring all records are collected, preserved, and submitted at the end. The Study Director oversees the planning, execution, and documentation of the study, and ensures that raw data, documentation, protocols, specimens, and the final study report are properly prepared and archived for submission to the sponsor or regulatory authorities. They act as the central point of responsibility for ensuring the integrity and completeness of the study package. The Quality Assurance Unit conducts audits and monitors GLP compliance, but they don’t own the submission of data. The sponsor oversees the project from a funding and oversight perspective, and the FDA is the regulatory body that receives the submission.

In GLP, the person coordinating the study’s conduct and data integrity is responsible for ensuring all records are collected, preserved, and submitted at the end. The Study Director oversees the planning, execution, and documentation of the study, and ensures that raw data, documentation, protocols, specimens, and the final study report are properly prepared and archived for submission to the sponsor or regulatory authorities. They act as the central point of responsibility for ensuring the integrity and completeness of the study package.

The Quality Assurance Unit conducts audits and monitors GLP compliance, but they don’t own the submission of data. The sponsor oversees the project from a funding and oversight perspective, and the FDA is the regulatory body that receives the submission.